Genetic Collection Protocol

Last updated: May 19, 2025
Sponsor: Arbor Research Collaborative for Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT05272319
Genetic Collection - ChiLDReN
  • Ages 24-25
  • All Genders

Study Summary

This study involves the one-time collection of whole blood or saliva samples for the extraction and storage of DNA for use in ongoing and future ChiLDReN studies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • For Child Participants

  1. Previous enrollment in PROBE, BASIC, LOGIC, or MITOHEP

  2. Exited from one of the aforementioned studies.

  3. Consent for DNA sample collection obtained during enrollment during enrollmentto one of the aforementioned studies but sample not previously collected.

  4. Still followed at the clinical site.

  • For Biological Parent Participants

  1. Biological parents of previously consented child participant without collectionof a parental DNA biospecimen.

  2. Child still followed at the clinical site.

Exclusion

Exclusion Criteria:

  • For Child Participants

  1. Participant is deceased

  2. Participant exited from prior study due to violating eligibility criteria

  3. Participant cannot be contacted

  • For Biological Parent Participants

  1. Non-biological parent

  2. Child DNA was not previously collected and will not be collected in this study

Study Design

Total Participants: 2230
Study Start date:
April 06, 2022
Estimated Completion Date:
May 31, 2029

Study Description

The purpose of this study is to establish a mechanism to collect a genetic biosample from the participants and their biological parents previously enrolled into clinical research under ChiLDReN-supported protocols (PROBE, BASIC, LOGIC, and MITOHEP). The samples will be linked to the data previously collected on the participant. Samples will be stored in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) specimen repository and will be used in ongoing and future Network and Ancillary Studies of ChiLDReN to further address the pathophysiology and outcomes of these liver diseases.

Connect with a study center

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1XG
    Canada

    Active - Recruiting

  • Children's Hospital of Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • UCSF Benioff Children's Hospital

    San Francisco, California 94143
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Lurie Children's Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Riley Hospital for Children

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Texas Children's Hospital; Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Texas Children's Liver Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84113
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

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